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CARDIOVASCULAR PRODUCT UPDATE AND EVALUATION What’s Hot, What’s Not, What’s In, What’s Out Balloons In this day of increasingly limited resources, we are always looking for ways to decrease costs in the catheterization laboratory. For most of us, the largest single recurrent expense is the balloon catheter. Therefore, a true balloon “workhorse” would be desirable. This balloon should be useful in 80% of all cases and complement newer tech- nologies. Is such a balloon catheter possible? Well, at first I would wager against it. Every laboratory and every interventionalist has their own pet rea- son for using a particular balloon and rarely is it based on scientific fact. Among the four of us, we all have different “workhorses,” and the consen- sus is that, basically, they all work in most cases. In this issue, we will review two new balloons, the Helix (Cordis Corp., Miami, FL, USA) and the Mirage (SciMed Life Systems, Inc., Maple Grove, MN, USA). These balloons have some unique features that permit versatility and once again demonstrate that balloon technology is still improving and evolving. Helix. The Helix is a minimal compliance bal- loon that is available in sizes from 2.0 mm to 4.0 mm. It has a “Y” connector at the proximal end, and markers on the proximal and distal shaft. It can accommodate up to a 0.018-inch wire. The balloon is nominal at 6-8 atmospheres (atrn) and is only slightly compliant. Its rated burst pressure is 8 atm, but experience is that it can be used up to 14 atm without rupturing. Once the balloon has been inflated, some “winging” occurs, but it is minimal and rarely prevents recrossing. The com- pany-provided balloon profiles reveals that it is comparable to most of the 0.014-inch over-the- wire balloons. Due to its coil design, the balloon in clinical experience has proven to be trackable and pushable. Experience to date with this balloon has been satisfying. Because of our usage of Doppler and Address for reprints: Robert Ginsburg, M.D., University of Colorado, Health Sciences Center, Campus Box B-132, Den- ver, CO 80262. Fax: (303) 270-4396. glidewires, our frequent need for 0.018-inch wires for total occlusions and lasers, and our frequent usage of urokinase, the larger lumen has obviated the need for the use of other balloon catheters or infusion catheters. One thing that could be redesigned is the “Y” connector at the proximal end. The “0” ring is difficult to open and close, and overall is awk- ward to operate. Mirage. This is a newer version of the popular Shadow (SciMed Life Systems, Inc.). The bal- loon is an over-the-wire design that can accom- modate an 0.018-inch wire. The published profile is 0.035 inch (2.5-mm balloon), and the distal shaft is 2.9 Fr. The balloon is compliant, the nom- inal pressure is 6 atm and the rated burst pressure is 9 atm. Overall, the catheter is pushable and trackable. Its “winging” characteristics are simi- lar to the Helix. The 0.018-inch lumen permits greater flexibility for use in the catheterization laboratory as men- tioned above. There are no shaft markers, and there is no “y” connector at the proximal end. Overall, the Mirage and Helix provide large lumen balloon catheters with 0.014-inch balloon profiles. Both balloons provide maximal utility for a variety of possible uses in the catheteriza- tion laboratory. Whether or not the end user con- siders these characteristics sufficient enough to use these balloons for general use will be deter- mined by time. Coronary Wires Reflex Wire. The Reflex is a new guidewire being produced by Cordis Corp. It has several differences from the other guidewires commonly used during angioplasty. The docking system is easy and fast to use and does live up to its name-the CINCH. For those of you who have anxiety tremors, you will find this docking system to be an advantage. The Reflex wire is radiopaque throughout its length and can make visualization difficult in small vessels. The distal tip is one piece rather Vol. 5, No. 1, 1992 Journal of Interventional Cardiology 67

What's Hot, What's Not, What's In, What's Out

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Page 1: What's Hot, What's Not, What's In, What's Out

CARDIOVASCULAR PRODUCT UPDATE AND EVALUATION

What’s Hot, What’s Not, What’s In, What’s Out

Balloons

In this day of increasingly limited resources, we are always looking for ways to decrease costs in the catheterization laboratory. For most of us, the largest single recurrent expense is the balloon catheter. Therefore, a true balloon “workhorse” would be desirable. This balloon should be useful in 80% of all cases and complement newer tech- nologies.

Is such a balloon catheter possible? Well, at first I would wager against it. Every laboratory and every interventionalist has their own pet rea- son for using a particular balloon and rarely is it based on scientific fact. Among the four of us, we all have different “workhorses,” and the consen- sus is that, basically, they all work in most cases.

In this issue, we will review two new balloons, the Helix (Cordis Corp., Miami, FL, USA) and the Mirage (SciMed Life Systems, Inc., Maple Grove, MN, USA). These balloons have some unique features that permit versatility and once again demonstrate that balloon technology is still improving and evolving.

Helix. The Helix is a minimal compliance bal- loon that is available in sizes from 2.0 mm to 4.0 mm. It has a “Y” connector at the proximal end, and markers on the proximal and distal shaft. It can accommodate up to a 0.018-inch wire. The balloon is nominal at 6-8 atmospheres (atrn) and is only slightly compliant. Its rated burst pressure is 8 atm, but experience is that it can be used up to 14 atm without rupturing. Once the balloon has been inflated, some “winging” occurs, but it is minimal and rarely prevents recrossing. The com- pany-provided balloon profiles reveals that it is comparable to most of the 0.014-inch over-the- wire balloons. Due to its coil design, the balloon in clinical experience has proven to be trackable and pushable.

Experience to date with this balloon has been satisfying. Because of our usage of Doppler and

Address for reprints: Robert Ginsburg, M.D., University of Colorado, Health Sciences Center, Campus Box B-132, Den- ver, CO 80262. Fax: (303) 270-4396.

glidewires, our frequent need for 0.018-inch wires for total occlusions and lasers, and our frequent usage of urokinase, the larger lumen has obviated the need for the use of other balloon catheters or infusion catheters.

One thing that could be redesigned is the “Y” connector at the proximal end. The “0” ring is difficult to open and close, and overall is awk- ward to operate.

Mirage. This is a newer version of the popular Shadow (SciMed Life Systems, Inc.). The bal- loon is an over-the-wire design that can accom- modate an 0.018-inch wire. The published profile is 0.035 inch (2.5-mm balloon), and the distal shaft is 2.9 Fr. The balloon is compliant, the nom- inal pressure is 6 atm and the rated burst pressure is 9 atm. Overall, the catheter is pushable and trackable. Its “winging” characteristics are simi- lar to the Helix.

The 0.018-inch lumen permits greater flexibility for use in the catheterization laboratory as men- tioned above. There are no shaft markers, and there is no “y” connector at the proximal end.

Overall, the Mirage and Helix provide large lumen balloon catheters with 0.014-inch balloon profiles. Both balloons provide maximal utility for a variety of possible uses in the catheteriza- tion laboratory. Whether or not the end user con- siders these characteristics sufficient enough to use these balloons for general use will be deter- mined by time.

Coronary Wires

Reflex Wire. The Reflex is a new guidewire being produced by Cordis Corp. It has several differences from the other guidewires commonly used during angioplasty. The docking system is easy and fast to use and does live up to its name-the CINCH. For those of you who have anxiety tremors, you will find this docking system to be an advantage.

The Reflex wire is radiopaque throughout its length and can make visualization difficult in small vessels. The distal tip is one piece rather

Vol. 5 , No. 1, 1992 Journal of Interventional Cardiology 67

Page 2: What's Hot, What's Not, What's In, What's Out

GINSBURG. ET AL.

than welded. This prevents prolapse and clini- cally has demonstrated excellent torque re- sponse. The wire comes in three degrees of stiff- ness and with straight or fixed tips. It will be available in 0.014-inch and 0.018-inch diameters.

Wires, like balloons, can be subjective. If it works, use it. The Reflex wire nicely comple- ments the Cordis family line of interventional de- vices.

Intraaortic Balloon Pump

The Kontron KAAT I1 (Kontron Instruments, Inc., Everett, MA, USA) is a new intraaortic bal- loon pump that is designed for air ambulance transport or in-hospital use. It is relatively light- weight and compact compared to other balloon systems, and is designed with transport in mind. It has a complete digital display module that can be separated from the main unit. Overall, if your hospital does frequent transport, then the KAAT I1 is worth evaluating and comparing to the other units already on the market.

Device Follow-Up

Simpson Atherocath. This directional atherec- tomy catheter (Devices for Vascular Interven-

tion, Redwood City, CA, USA) has been avail- able for more than a year and most interventional- ists now are trained in its use. A quick survey has found that the use of the device is primarily complementary to balloons and reserved for os- tial, noncalcified, and eccentric lesions usually in the left anterior descending coronary artery (LAD). Complications have decreased with expe- rience. Everyone comments on the “gorgeous” angiographic results, but the precise mechanism for this is unclear-probably a little bit of every- thing! Restenosis has been a recurrent problem and does not seem to be altered by this device in most cases.

If you have comments, suggestions, or prod- ucts you would like evaluated, please do not hesi- tate to contact us.

Robert Ginsburg University of Colorado

Denver, Colorado Paul Teirstein

Scripps Clinic and Research Foundation La Jolla, California

Jerry Segal George Washington Hospital

Washington, D. C. Mike Chang

Mercy General Hospital Sacramento, California

68 Journal of Interventional Cardiology Vol. 5 , No. 1, 1992